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市场调查报告书
商品编码
1934225
mRNA治疗药物合约开发和生产市场-全球产业规模、份额、趋势、机会及预测(按应用、适应症、最终用户、地区和竞争格局划分,2021-2031年)mRNA Therapeutics Contract Development & Manufacturing, Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Application, By Indication, By End user, By Region & Competition, 2021-2031F |
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全球 mRNA 疗法合约开发和生产 (CDMO) 市场预计将从 2025 年的 99.9 亿美元成长到 2031 年的 158.3 亿美元,复合年增长率为 7.97%。
该市场由专门从事信使传讯RNA(mRNA)药物和疫苗的开发、配方和商业化生产外包服务的专业机构组成。推动市场成长的主要因素是针对感染疾病以外疾病(例如肿瘤和罕见遗传疾病)的mRNA候选药物临床研发管线不断扩大,这催生了对外部生产能力的需求。因此,製药开发商正与合约研发生产机构(CDMO)合作,以利用现有基础设施并降低自建设施相关的资本风险。美国药品研究与製造商协会(PhRMA)2025年的数据也支持了这一趋势(265个DNA或RNA治疗计划正在研发中)。
| 市场概览 | |
|---|---|
| 预测期 | 2027-2031 |
| 市场规模:2025年 | 99.9亿美元 |
| 市场规模:2031年 | 158.3亿美元 |
| 复合年增长率:2026-2031年 | 7.97% |
| 成长最快的细分市场 | 感染疾病 |
| 最大的市场 | 北美洲 |
然而,市场面临许多挑战,例如缺乏复杂mRNA合成和脂质奈米颗粒包覆所需的专业技术知识和生产能力。这些生产过程的复杂性要求高技能人员和严格的品管,而这两方面目前都远远无法满足日益增长的需求。人才短缺,加上原料成本上涨和供应链受限,导致生产瓶颈,有可能延缓临床开发进程,并限制整个产业的扩充性。
CDMO产业的关键驱动力之一是全球mRNA疫苗和治疗药物研发管线的快速扩张,因为研发人员正积极将重心从感染疾病预防转向肿瘤和罕见遗传疾病。这种向复杂治疗领域的多元化发展,对专业製程开发和临床规模生产的需求日益迫切,而鲜有生物製药公司能够独立完成这些工作。因此,CDMO被要求为新型药物载体和先进脂质奈米颗粒製剂提供支持,导致后期研发服务合约激增。 BioNTech在2025年5月宣布其多元化的癌症治疗管线已进入20多项II期和III期临床试验,这一趋势尤为明显,凸显了先进候选药物的规模之大,以及对强大的外部生产基础设施的需求。
同时,内部生产面临的高昂资本和技术壁垒正推动着向策略外包的结构性转变。建造符合cGMP标准的mRNA生产设施需要对专用设备和封装技术进行大量投资,且熟练劳动力短缺。这种财务压力促使製药开发商与成熟的合约研发生产机构(CDMO)合作,以降低风险并实现即时规模化生产,同时避免内部建设所需的大量资本投入。例如,赛默飞世尔科技公司于2025年4月宣布,将追加20亿美元投资以加强在美国的业务,其中15亿美元将用于扩大生产能力。此外,截至2025年5月,三星生物製剂公司已累计获得总额约24亿美元的契约製造订单,凸显了该产业对外包能力的依赖。
全球mRNA疗法CDMO市场成长面临的主要挑战之一是专业技术人才和生产能力的严重短缺。 mRNA疗法的生产涉及高度复杂的工艺,例如脂质奈米颗粒包封,这需要具备先进科学知识和精准操作技能的人员。目前,此类专业人员的供应不足以满足药物研发人员日益增长的需求。人才短缺造成了严重的生产瓶颈,并阻碍了CDMO有效扩大营运规模以应对新计画的涌入。
劳动力和产能的限制直接阻碍了市场扩张,导致临床开发週期和产品商业化进程显着延迟。如果没有足够的人员和高技能人才,CDMO(合约研发生产机构)就无法保证复杂mRNA候选药物所需的产量和品管。根据生物产业协会2024年的数据,预计到2030年,生命科学领域将出现13.3万名技术纯熟劳工的缺口,这将威胁到该产业维持成长动能的能力。这种人力资本短缺限制了CDMO服务向感染疾病以外的领域多元化发展,最终缩小了其整体潜在市场规模。
自扩增和环状RNA技术的出现正迫使合约研发生产机构(CDMO)改造其生产平台,以适应新一代药物递送系统。与传统mRNA不同,这些技术能够实现持续的蛋白质表现和更高的稳定性,但这需要特殊的纯化通讯协定和复杂的质体构建,超出了标准生产设备的承载能力。 CDMO正积极拓展这些能力,以收购那些有望降低剂量和生产成本的早期专案。这使得CDMO成为缺乏内部专业基础设施的生物技术创新者的重要合作伙伴。感染疾病防范创新联盟(CEPI)的案例便反映了这种关注。该联盟于2025年3月向Genova Biopharmaceuticals公司拨款高达1,338万美元,用于推进自扩增mRNA疫苗的研发。
同时,采用自动化连续生产流程正成为CDMO(合约研发产量机构)提升批次间一致性、缩短週转时间的关键差异化优势。製造商正从静态批次处理转向整合式数位化系统,利用即时分析监测包封效率和纯度,从而最大限度地减少人为错误,加快批次放行。这种营运转型对于满足个人化医疗和快速疫苗宣传活动等对速度的严格要求至关重要,因为上市时间是关键的竞争优势。例如,Recipharm在2025年6月发布的企业资料更新报告中指出,新连续生产平台的实施已将其RNA生产週期从25天缩短至5天。
The Global mRNA Therapeutics Contract Development and Manufacturing (CDMO) Market is projected to increase from USD 9.99 billion in 2025 to USD 15.83 billion by 2031, expanding at a CAGR of 7.97%. This market consists of specialized organizations offering outsourcing services for the development, formulation, and commercial manufacturing of messenger RNA-based drugs and vaccines. Growth is primarily driven by the widening clinical pipeline for mRNA candidates targeting conditions beyond infectious diseases, such as oncology and rare genetic disorders, which creates a need for external manufacturing capabilities. Consequently, pharmaceutical developers are partnering with CDMOs to utilize existing infrastructure and reduce capital risks associated with building internal facilities, a trend supported by PhRMA data from 2025 indicating 265 DNA or RNA therapeutic projects in the pipeline.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 9.99 Billion |
| Market Size 2031 | USD 15.83 Billion |
| CAGR 2026-2031 | 7.97% |
| Fastest Growing Segment | Infectious Diseases |
| Largest Market | North America |
However, the market faces a significant obstacle regarding the scarcity of specialized technical expertise and manufacturing capacity needed for complex mRNA synthesis and lipid nanoparticle encapsulation. The intricate nature of these production processes requires highly skilled personnel and strict quality controls, both of which are currently in short supply compared to rising demand. This talent gap, alongside high raw material costs and supply chain limitations, results in production bottlenecks that threaten to delay clinical timelines and limit the sector's overall scalability.
Market Driver
The primary catalyst propelling the CDMO sector is the rapid expansion of the global mRNA vaccines and therapeutics pipeline, as developers aggressively shift focus from infectious disease prophylaxis to oncology and rare genetic disorders. This diversification into complex therapeutic areas creates an urgent demand for specialized process development and clinical-scale manufacturing that few biopharmaceutical companies can handle internally. Consequently, CDMOs are required to support novel cargo and sophisticated lipid nanoparticle formulations, leading to a surge in service agreements for late-stage development. This trend is highlighted by BioNTech, which reported in May 2025 that its diversified oncology pipeline had advanced to include over 20 active Phase 2 and Phase 3 clinical trials, underscoring the volume of advanced candidates requiring robust external manufacturing infrastructure.
Simultaneously, high capital and technical barriers to in-house manufacturing are forcing a structural shift toward strategic outsourcing. Establishing cGMP-compliant mRNA production facilities demands massive financial investment for specialized equipment and encapsulation technologies, compounded by a scarcity of skilled technical personnel. This financial pressure drives pharmaceutical developers to partner with established CDMOs to mitigate risk and gain immediate scalability without the capital intensity of self-building. For instance, Thermo Fisher Scientific committed an additional $2 billion in April 2025 to enhance U.S. operations, with $1.5 billion allocated to manufacturing expansion, while Samsung Biologics secured approximately $2.4 billion in cumulative contract manufacturing orders by May 2025, reflecting the industry's critical reliance on outsourced capacity.
Market Challenge
The primary challenge hindering the growth of the Global mRNA Therapeutics CDMO Market is an acute shortage of specialized technical expertise and manufacturing capacity. Producing mRNA-based therapeutics involves highly intricate processes, such as lipid nanoparticle encapsulation, which demand a workforce possessing advanced scientific proficiency and precise operational skills. Currently, the supply of such specialized talent is insufficient to meet the surging demand from pharmaceutical developers. This workforce gap creates significant production bottlenecks, preventing CDMOs from effectively scaling operations to accommodate the influx of new projects.
These labor and capacity constraints directly impede market expansion by causing substantial delays in clinical timelines and commercial product releases. Without a fully staffed and skilled workforce, CDMOs cannot guarantee the throughput and quality control required for complex mRNA candidates. Data from the BioIndustry Association in 2024 projects a shortfall of 133,000 skilled workers in the life sciences sector by 2030, a deficit that threatens the industry's ability to maintain its growth trajectory. This scarcity of human capital limits the sector's ability to diversify beyond infectious diseases, thereby restricting the overall addressable market for CDMO services.
Market Trends
The emergence of self-amplifying and circular RNA technologies is compelling Contract Development and Manufacturing Organizations to re-engineer their production platforms for next-generation cargoes. Unlike conventional mRNA, these modalities offer sustained protein expression and enhanced stability, necessitating specialized purification protocols and longer plasmid constructs that challenge standard manufacturing footprints. CDMOs are aggressively expanding these capabilities to capture early-stage programs that promise lower dosage requirements and reduced cost of goods, positioning themselves as essential partners for biotech innovators lacking internal specialized infrastructure. This focus is evidenced by the Coalition for Epidemic Preparedness Innovations, which awarded up to $13.38 million to Gennova Biopharmaceuticals in March 2025 to advance a self-amplifying mRNA vaccine.
Simultaneously, the implementation of automated and continuous production workflows is becoming a critical differentiator for CDMOs seeking to improve batch consistency and reduce turnaround times. Manufacturers are moving away from static batch processing toward integrated digital systems that utilize real-time analytics to monitor encapsulation efficiency and purity, thereby minimizing human error and accelerating lot release. This operational shift is essential for meeting the stringent speed requirements of personalized therapeutics and rapid-response vaccine campaigns, where time-to-market is the primary competitive advantage. For example, in a June 2025 corporate update, Recipharm reported reducing RNA production timelines from 25 days to 5 days by deploying a new continuous manufacturing platform.
Report Scope
In this report, the Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market.
Global mRNA Therapeutics Contract Development & Manufacturing (CDMO) Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: